(143 days)
Not Found
No
The device description focuses on the laser technology and user-adjustable parameters (pulse duration, power, interval). There is no mention of AI, ML, image processing for analysis, or any data-driven decision-making within the device's operation.
Yes
The device is indicated for the treatment of various medical conditions, including retinal abnormalities, glaucoma, and choroidal neovascularization, which aligns with the definition of a therapeutic device.
No
The device is described as equipment for making human retinal photocoagulation to treat various eye conditions, indicating it is a therapeutic or surgical device rather than a diagnostic one.
No
The device description clearly outlines hardware components such as encoders, a color display, a touch-screen film, a solid-state laser, and compatible delivery devices (slit lamp adapters, LIO, endoprobe). While it mentions "navigation software," this software is integral to controlling the hardware and is not the sole component of the medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Photocoagulator Opto Mitra Yellow Laser is a surgical laser used for photocoagulation of tissues within the eye. It directly interacts with the patient's body during a surgical procedure.
- Intended Use: The intended use clearly states it is for "photocoagulation of both anterior and posterior segments" and "ophthalmic surgical procedures." This involves direct treatment of the patient, not the analysis of specimens outside the body.
- Device Description: The description details a surgical laser system and its components for delivering laser energy to tissue. There is no mention of collecting or analyzing biological samples.
Therefore, the device falls under the category of a surgical device or therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Indicated for use in photocoagulation of both anterior and posterior segments, including:
- Retinal photocoagulation, panretinal photocoagulation and intravitreal . endophotocoagulation of vascular and structural abnormalities of the retina and choroids, including:
- Proliferative and nonproliferative diabetic retinopathy
- Choroidal neovascularization
- Branch retinal vein occlusion
- The treatment of choroidal neovascularization associated with wet age related macular degeneration Retinal tears and detachments
- Retinopathy of prematurity
- Iridotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and open angle glaucoma
The Opto Mitra Yellow Laser is indicated for retinal photocoagulation. Used for the following ophthalmic medical condition end treatment:
- Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroids, including:
- Proliferative and nonproliferative diabetic retinopathy
- Choroidal neovascularization
- Branch retinal vein occlusion
- The treatment of choroidal neovascularization associated with wet age related macular degeneration Retinal tears and detachments
- Retinopathy of prematurity
- Iridotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and open angle glaucoma
Product codes (comma separated list FDA assigned to the subject device)
HQF, GEX
Device Description
The Photocoagulator Opto Mitra Yellow Laser is equipment capable of making human retinal photocoagulation by laser application at 586nm (yellow laser). The coagulation (clotting) of tissue using a laser which produces light in the visible yellow (586nm) wavelength that is selectively absorbed by hemoglobin, the pigment in red blood cells, in order to seal off bleeding blood vessels. Photocoagulation has diverse uses such as, for example, in cancer treatment to destroy blood vessels entering a tumor and depriving it from nutrients; in the treatment of a detached retina, to destroy abnormal blood vessels in the retina, to treat tumors in the eye, etc.
The equipment consists of three encoders which enable the physician to adjust the pulse duration, the laser power and the interval between successive pulses. All information is displayed on a color display 240x324 pixels TFT technology. On this display there is a touch-screen film responsible for the navigation software and by setting preferences, such as loudness, intensity laser sighting and display brightness.
Physicians have the option of applying single pulses or pulse trains previously adjusted. Power levels ranging from 50mW up to 2000MW, with resolution of 10mW. The duration can be set between 100ms and 3000 ms with a resolution of 10ms. The interval between pulses can be set between 100ms and 3000ms with 10ms resolution or can be set to single pulse (in this case, the range is set to zero).
The Opto Mitra Yellow Laser beam has a wavelength of 586nm, which is in the visible spectrum and is a yellow light. A red aiming beam is used to position the treatment Yellow beam prior to delivery.
The Opto Mitra Yellow Laser is a solid state, Optical Pumped Semiconductor surgical laser.
It's an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 586nm.
Compatible delivery devices include: slit lamp adapters/, laser indirect ophthalmoscopes (LIO) and endoprobe. All these accessories are specific for Opto Mitra Yellow Laser.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
retina and choroids, anterior and posterior segments
Indicated Patient Age Range
Individuals of all ages with diabetic retinopathy, glaucoma, or who have suffered any trauma causing a retinal detachment. Premature child with symptoms of prematurity retinopathy.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance data and conclusions from non-clinical tests Laboratory testing was conducted to validate and verify that the proposed device, Opto Mitra Yellow Laser meets all design specifications and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows the word "opto" in a bold, sans-serif font. Below the word "opto" is the tagline "Science in Sight" in a smaller, italicized font. The word "opto" is the main focus of the image, with the tagline providing additional context.
Executive Summary
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
1. Submitter Information
Submitter: Opto Eletrônica S/A
Address: NO. 1071 - Joaquim Augusto Ribeiro de Souza street- Jardim Santa Felícia - São Carlos - SP/ Brazil
Phone: + 55 (16) 2106-7029
Contact name: Paulo Aneas Lichti
Prepared on: 03/23/2011
Registration number: 9613205
2. U.S. Agent to respond to FDA requests:
Establishment: Opto Usa Corporation
Contact Person: Paulo Aneas Lichti
Address: 12550 BISCAYNE BLVD, 605, MIAMI - FL - 33181
Phone: 1 305 981 2979 - Fax: 1 305 981 2980
3. Device Classification Name
Device Name: Opto Mitra Yellow Laser
Common name: Ophthalmic Laser, Surgical Laser
Sec: 05 - page 1 of 7
1
K11643
Image /page/1/Picture/1 description: The image shows the word "opto" in a bold, sans-serif font. The letters are closely spaced and appear to be filled with a solid black color. The overall design is simple and modern, with a focus on readability and visual impact.
Science in Sight
Classification name:
HQF, Laser, Ophthalmic
GEX, Powered Laser Surgical Instrument
Regulation Number:
21 CFR 886.4390, Ophthalmic Laser
21 CFR 878.4810, Surgical Devices
Regulatory Class:
Class II
Performance standards:
21 CFR 1040.10
Predicate Device Name: 4.
Iridex IQ 577, Iridex Corporation, K071687
Nidek Multicolor Laser Photocoagulator System MC-500, K110228
Product Description 5.
The Photocoagulator Opto Mitra Yellow Laser is equipment capable of making human retinal photocoagulation by laser application at 586nm (yellow laser). The coagulation (clotting) of tissue using a laser which produces light in the visible yellow (586nm) wavelength that is selectively absorbed by hemoglobin, the pigment in red blood cells, in order to seal off bleeding blood vessels. Photocoagulation has diverse uses such as, for example, in cancer treatment to destroy blood vessels entering a tumor and depriving it from nutrients; in the
2
Image /page/2/Picture/1 description: The image shows the logo for "opto" with the tagline "Science in Sight" underneath. The word "opto" is written in a bold, sans-serif font, with the letters connected to each other. The tagline is written in a smaller, italicized font. The logo appears to be slightly distressed, giving it a textured look.
treatment of a detached retina, to destroy abnormal blood vessels in the retina, to treat tumors in the eye, etc.
The equipment consists of three encoders which enable the physician to adjust the pulse duration, the laser power and the interval between successive pulses. All information is displayed on a color display 240x324 pixels TFT technology. On this display there is a touch-screen film responsible for the navigation software and by setting preferences, such as loudness, intensity laser sighting and display brightness.
Physicians have the option of applying single pulses or pulse trains previously adjusted. Power levels ranging from 50mW up to 2000MW, with resolution of 10mW. The duration can be set between 100ms and 3000 ms with a resolution of 10ms. The interval between pulses can be set between 100ms and 3000ms with 10ms resolution or can be set to single pulse (in this case, the range is set to zero).
Indicated for Use 6.
Indicated for use in photocoagulation of both anterior and posterior segments, including:
- Retinal photocoagulation, panretinal photocoagulation and intravitreal . endophotocoagulation of vascular and structural abnormalities of the retina and choroids, including:
- イ Proliferative and nonproliferative diabetic retinopathy
- イ Choroidal neovascularization
- V Branch retinal vein occlusion
- イ The treatment of choroidal neovascularization associated with wet age related macular degeneration Retinal tears and detachments
- V Retinopathy of prematurity
3
Image /page/3/Picture/1 description: The image shows the word "opto" in a bold, sans-serif font. The letters are closely spaced and appear to be slightly distressed, giving them a textured look. The overall impression is a simple, yet impactful logo or wordmark.
Science in Sight
- . Iridotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and open angle glaucoma
Intended Use 7.
Intended for use in ophthalmic surgical procedures.
8. Target Population
Individuals of all ages with diabetic retinopathy, glaucoma, or who have suffered any trauma causing a retinal detachment. Premature child with symptoms of prematurity retinopathy.
Technical Characteristics 9.
The Opto Mitra Yellow Laser beam has a wavelength of 586nm, which is in the visible spectrum and is a yellow light. A red aiming beam is used to position the treatment Yellow beam prior to delivery.
The Opto Mitra Yellow Laser is a solid state, Optical Pumped Semiconductor surgical laser.
It's an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 586nm.
Compatible delivery devices include: slit lamp adapters/, laser indirect ophthalmoscopes (LIO) and endoprobe. All these accessories are specific for Opto Mitra Yellow Laser.
Laser specification: .
.. .
- o Laser of 586nm (± 3nm), with a maximum output of 2000mW, resolution of 10mW and maximum Error of ± 20% in relation to the power set;
- o Laser Aim of 635nm (± 20nm), with a maximum output of 0.7mW (± 0.2mW);
Sec: 05 - page 4 of 7
4
KIII1643
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Science in Sight
Pulse Duration: .
- o From 10ms to 1000ms with a maximum Error of 10%.
Interval between Pulses: .
- o From 50ms to 3000ms with a maximum Error of 10%.
- o The single pulse can be used This option enables activating a single pulse with a pre-selected duration.
t
Operating range in the FastPulse configuration: .
- o FastPulse Period: from 1800 us to 2200 us (± 100 us);
- o Duty-Cycle of the FastPulse : from 5% to 15% (± 1%) of the period chosen ( time "on" );
Operational Characteristics: .
- o Autoprograming according to the type of accessory coupled to the Opto Mitra Yellow Laser, through the Autokey;
- o Aiming Beam and Power Laser Divergence: single optical path, with coupling of the beams set at 100% of the units produced;
- o Automatic mode selection according to the accessory used, through the AutoKev:
- o Accessories such as Endoprobes, Slit Lamp Adapter and Ophthalmoscopes are connected to the main unit through the "optical fiber" opening, which is an optical-mechanical connector;
- o Emergency Key;
- TFT Color Display with 32000 colors; o
- o Touchscreen Activation of commands by simply touching the display;
...
- o Control buttons without final stroke and with back lighting.
5
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10. Accessories
- Eye Safety Filter
- Pedal Multifunctional .
- Slit Lamp Adapter .
11. Compatible Delivery Devices
- Ophthalmoscope .
- Probe .
12. Performance Standard
Opto Mitra Yellow Laser is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards, including:
- IEC 60825-1:2007, Safety of laser products - Part I : Equipment ● classification, requirements and user's quide.
- IEC 60601-2-22: Ed 1995, Medical electrical Equipment Part 2 : ● Particular requirements for the safety of diagnostic and therapeutic laser equipment.
- IEC 60601-1: 1988 + AI: 1991 + A2:1995, Medical Electrical equipment . -Part I : general requirement for safety.
- IEC 60601-1-2: 200 1, Medical Electrical equipment -Part I : General . safety-2, Collateral requirements for Standard : electromagnetic compatibility - requirements and tests.
- IEC 6060 1-1-4: 2000, Medical electrical equipment Part I : General . requirements for safety -4 - Collateral standard : Programmable electrical medical systems, edition 1.1.
- The device also complies with European Medical Directive 93/42/EEC . 2007/47/EEC and the Performance ਜ Amendment US Federal Standards 21 CFR 1002. 10 Requirements (21 CFR 1040. 10 and 21 CFR 1040.11 for Class IV Laser). Part 1010.2 and 1010.3,Part 820 - Quality System Requlation, and has passed ISO 9001 and 13485 System Certification.
- IEC 62304:2006, medical device software Software life cycle processes .
6
111643
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Science in Sight
Discussion of similarities and Differences from the Predicate Product 13.
Opto Mitra Yellow Laser shares the same indications for use and safety compliance, similar design features, functional features, and therefore are substantially equivalent to the predicate device , K071687 and K110228 . In addition, a review of the predicate device shows that the Opto Mitra Yellow Laser is safe and effective as the predicate device as they share equivalent specifications / characteristics and are used to perform the same indicated surgical procedures.
The only difference in the specifications/characteristics of the Opto Mitra Yellow Laser and its predicate K071687 is as follows:
-
- Opto Mitra Yellow Laser has a wavelength of 586nm and 577nm for IQ 577. This difference is not viewed as being clinically significant.
Conclusion:
Opto Mitra Yellow Laser uses the same fundamental technology features as the IQ 577 and delivers the same level of effectiveness. Therefore, the conclusion that there is no significant difference in the basic function, safety and effectiveness between the K071687 and K110228 (Predicate Device) and the Opto Mitra Yellow Laser.
The Opto Mitra Yellow Laser is substantially equivalent to predicate devices currently legally marketed for treatments in ophthalmology.
- Non-clinical performance data and conclusions from non-clinical tests Laboratory testing was conducted to validate and verify that the proposed device, Opto Mitra Yellow Laser meets all design specifications and ાંડ substantially equivalent to the predicate device.
15. Conclusion
Based on the information in this notification we conclude that Opto Mitra Yellow Laser is substantially equivalent to predicate devices currently legally marketed for the indication of retinal photocoagulation laser. Only applicable for use in ophthalmology.
The Opto Mitra Yellow Laser shares the same intended use, indications for use, and similar technical characteristics to the predicate device.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
NOV - 3 2011
Opto Eletronica S/A % Mr. Paulo Aneas Lichti Joaquim A.R. de Souza Street 1071 - Jardim Santa Felicia Sao Carlos, San Paulo Brazil 13563-330
Re: K111643
Trade/Device Name: Opto Mitra Yellow Laser Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HOF Dated: October 21, 2011 Received: October 24, 2011
Dear Mr. Lichti:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
8
Page 2 - Mr. Paulo Aneas Lichti
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use Form
510(k) Number (if know): K111643
Device Name: Opto Mitra Yellow Laser
The Opto Mitra Yellow Laser is indicated for retinal photocoagulation. Used for the following ophthalmic medical condition end treatment:
- Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroids, including:
- く Proliferative and nonproliferative diabetic retinopathy
- イ Choroidal neovascularization
- イ Branch retinal vein occlusion
- く The treatment of choroidal neovascularization associated with wet age related macular degeneration Retinal tears and detachments
- イ Retinopathy of prematurity
- lridotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and open . angle glaucoma
Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVE
Neil R. Ogle Forman
(Division Sign Off)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_
Division of Surgical, Orthopedic, and Restorative Devices
| 510(k) Number | K 111 643 |
|---|---|
| Sec: 04 Page 1 of 1 |